Spiriva Respimat 2.5 microgram inhalation solution

Страна: Ирландия

Язык: английский

Источник: HPRA (Health Products Regulatory Authority)

Активный ингредиент:

Tiotropium

Доступна с:

Boehringer Ingelheim International GmbH

код АТС:

R03BB; R03BB04

ИНН (Международная Имя):

Tiotropium

дозировка:

2.5 microgram(s)

Фармацевтическая форма:

Inhalation solution

Тип рецепта:

Product subject to prescription which may be renewed (B)

Терапевтические области:

Anticholinergics; tiotropium bromide

Статус Авторизация:

Marketed

Дата Авторизация:

2007-09-14

тонкая брошюра

R1e/IE MT/PI/WS566
19.12.2022
1
PACKAGE LEAFLET: INFORMATION FOR THE USER
SPIRIVA
® RESPIMAT
® 2.5 MICROGRAM, INHALATION SOLUTION
tiotropium
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU
.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1. What Spiriva Respimat is and what it is used for
2. What you need to know before you take Spiriva Respimat
3. How to take Spiriva Respimat
4. Possible side effects
5. How to store Spiriva Respimat
6. Contents of the pack and other information
1.
WHAT SPIRIVA RESPIMAT IS AND WHAT IT IS USED FOR
Spiriva Respimat helps people who have chronic obstructive pulmonary
disease (COPD) or asthma to
breathe more easily. COPD is a long-term lung disease that causes
shortness of breath and coughing.
The term COPD is associated with the conditions chronic bronchitis and
emphysema. Asthma is a
long-term disease characterised by airway inflammation and narrowing
of the airways.
As COPD and asthma are long-term diseases you should take Spiriva
Respimat every day and not only
when you have breathing problems or other symptoms. When used to treat
asthma you should take
Spiriva Respimat in addition to so-called inhaled corticosteroids and
long-acting ß
2
agonists.
Spiriva Respimat is a long-acting bronchodilator that helps to open
your airways and makes it easier to
get air in and out of the lungs. Regular use of Spiriva Respimat can
also help you when you have on-
going shortness of breath related to your disease, and will help to
minimise the effects of the disease
on your everyday life. Daily use of Spiriva Respimat will also h

Характеристики продукта

Health Products Regulatory Authority
16 January 2023
CRN00CR24
Page 1 of 19
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Spiriva Respimat 2.5 microgram inhalation solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
The delivered dose is 2.5 microgram tiotropium per puff (2 puffs
comprise one medicinal dose) and is equivalent to 3.124
microgram tiotropium bromide monohydrate.
The delivered dose is the dose which is available for the patient
after passing the mouthpiece.
Excipient with known effect: This medicine contains 0.0011 mg
benzalkonium chloride in each actuation.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Inhalation solution
Clear, colourless, inhalation solution
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
COPD
Spiriva Respimat is indicated as a maintenance bronchodilator
treatment to relieve symptoms of patients with chronic
obstructive pulmonary disease (COPD).
Asthma
Spiriva Respimat is indicated as add-on maintenance bronchodilator
treatment in patients aged 6 years and older with severe
asthma who experienced one or more severe asthma exacerbations in the
preceding year (see sections 4.2 and 5.1).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The medicinal product is intended for inhalation use only. The
cartridge can only be inserted and used in the Respimat inhaler
(see 4.2).
Two puffs from the Respimat inhaler comprise one medicinal dose.
The recommended dose for adults is 5 microgram tiotropium given as two
puffs from the Respimat inhaler once daily, at the
same time of the day.
The recommended dose should not be exceeded.
In the treatment of asthma the full benefit will be apparent after
several doses of the medicinal product. In adult patients with
severe asthma, tiotropium should be used in addition to inhaled
corticosteroids (≥ 800 μg budesonide/day or equivalent) and
at least one controller.
Special populations
Geriatric patients can use tiotropium bromide at the recommended dose.
Renally impaired patients can use tiotropium br